FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 3822942
·
Received February 5, 2014
Report
- Report Number
- 1720753-2014-01195
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- October 8, 2013
- Report Date
- February 25, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR IRIS POTENTIOMETER WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS EXHIBITED COLLIMATOR IRIS POTENTIOMETER ERRORS RESULTING IN THE INABILITY TO BOOT TO A USABLE STATE. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74684 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |